Ex Vivo-activated Autologous Lymph Node Lymphocytes in Treating Patients With Chronic Lymphocytic Leukemia

M.D. Anderson Cancer Center

Status and phase

Completed

Phase 2

Conditions

Weight Loss

Fever

Anemia

Thrombocytopenia

Night Sweats

Lymphocytosis

Richter Syndrome

Lymphadenopathy

Recurrent Chronic Lymphocytic Leukemia

Cancer Fatigue

Infectious Disorder

Chronic Lymphocytic Leukemia

Secondary Malignant Neoplasm

Prolymphocytic Leukemia

Treatments

Biological: Ex Vivo-activated Autologous Lymph Node Lymphocytes

Other: Laboratory Biomarker Analysis

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02530515

P30CA016672 (U.S. NIH Grant/Contract)

2014-0830 (Other Identifier)

NCI-2015-01546 (Registry Identifier)

Details and patient eligibility

About

This phase II trial studies the side effects of ex vivo-activated autologous lymph node lymphocytes infusion and to see how well they work in treating patients with chronic lymphocytic leukemia. Biological therapies, such as ex vivo-activated autologous lymph node lymphocytes, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing.

Full description

PRIMARY OBJECTIVES:

I. To assess the feasibility and safety of infusion of autologous activated T-cells (ex vivo-activated autologous lymph node lymphocytes) in patients with chronic lymphocytic leukemia.

SECONDARY OBJECTIVES:

I. To study immune reconstitution following infusion of activated T-cells in patients with chronic lymphocytic leukemia.

II. To study the incidence of infections for up to 1 year following activated T cell infusion.

III. To study the overall response rates.

OUTLINE:

Patients receive infusion of ex vivo-activated autologous lymph node lymphocytes intravenously (IV) over 10-30 minutes on day 0.

Patients who have been previously treated on study, and subsequently need additional infusions, may be retreated with previously cryopreserved expanded cells at the same or lower dose level 6-12 months after the first infusion.

After completion of study treatment, patients are followed up at 1.5 years and then every 6 months for up to 5 years.

Enrollment

8 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

All patients must have a diagnosis of chronic lymphocytic leukemia (CLL) by immunophenotyping and flow cytometry analysis of blood or bone marrow
- Patients must meet criteria for treatment based on the criteria proposed by National Cancer Institute (NCI)-sponsored CLL Working Group to include at least one of the following:
  - Weight loss of more than 10% over the preceding 6 months; or
  - Extreme fatigue attributable to progressive disease; or
  - Fever or night sweats without evidence of infection; or
  - Worsening anemia (Rai stage Ill) or thrombocytopenia (Rai stage IV); or
  - Massive lymphadenopathy (> 10 cm) or rapidly progressive lymphocytosis (lymphocyte doubling time < 6 months); or
  - Prolymphocytic or Richter's transformation; or
- Patients with CLL who have received at least one prior line of therapy; or
- Patients with CLL who have frequent infections and/or recurrent secondary cancers
No active central nervous system (CNS) disease
All patients must have a Karnofsky performance score > 60%
Calculated creatinine clearance (by Cockcroft-Gault) of > 50 ml/min
Patients must not have untreated or uncontrolled life-threatening infection
Patients must sign informed consent

Exclusion criteria

Receipt of glucocorticoids (with the exception of inhaled glucocorticoid steroids for the use of allergic rhinitis or pulmonary disease) within 2 weeks of registration
Autoimmune disease related to CLL, e.g., idiopathic thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia, is permitted if not requiring active treatment